Sybron Dental Specialties: Medical Device Recall in 2015 - (Recall #: Z-1291-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500

Product Classification:

Class II

Date Initiated: February 11, 2015

Date Posted: March 25, 2015

Recall Number: Z-1291-2015

Event ID: 70551

Reason for Recall:

Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.

Status: Terminated

Product Quantity: 172

Code Information:

Part Number: 4513C or 4513-1. Lot Number: 2014030110

Distribution Pattern:

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

Voluntary or Mandated:

Voluntary: Firm initiated